Trilogy Trilogy 202 Ventilator, ChinaRecalls & reported problems
Respironics, Inc. · Trilogy 202 Ventilator, China · Class 2
All models of Philips Trilogy Ventilator (90) · Trilogy (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Respironics Trilogy 202 ventilator is a breathing machine. Many of the 304 reports describe circuit problems, device operating issues, battery problems, or error alarms and black screens. The reports include 1 death and 4 injuries, and no recalls name this device. Reports fell from 14 in the prior 12 months to 5 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 304
- Deaths reported
- 1
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 304 adverse event reports that list this exact device (DI 00606959022812), received between Nov 17, 2015 and Apr 24, 2026 — classified as 1 death, 4 injuries, 299 malfunctions.
The most frequently reported specific device problem is “Circuit Failure” (106 reports).
3 other recalls cover devices cleared under the same FDA submission (K093905); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Circuit Failure106
- Device Operational Issue50
- Battery Problem32
- Mechanical Problem30
- Device Displays Incorrect Message23
- Electrical /Electronic Property Problem20
- Failure to Charge14
- Failure to Power Up10
Patient problems
- No Clinical Signs, Symptoms or Conditions145
- No Patient Involvement84
- No Consequences Or Impact To Patient62
- Low Oxygen Saturation5
- No Known Impact Or Consequence To Patient5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Dyspnea2
- Asthma1
Recent adverse event reports
The 25 most recent of 304 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2026Device Alarm System; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY 202 VENTILATOR TUBING ALARM CANNOT BE USED, AND THE FAULT PERSISTS AFTER RESTARTING. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24977623 ↗MalfunctionMar 20, 2026Device Sensing Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A FAILED TEST STEP OCCURRED ON ATRILOGY202 VENTILATOR. THE DEVICE WAS NOT REPORTED TO BE IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE ROOT CAUSE ISN'T CONFIRMED AT THIS TIME. GOOD FAITH EFFORT ATTEMPTS WILL BE MADE TO GATHER ADDITIONAL INFORMATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647391 ↗MalfunctionMar 19, 2026Circuit Failure
THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 202 VENTILATOR WAS REPORTED TO HAVE BEEN EVALUATED BY REMOTE TECHNICAL SERVICE AND ONSITE TECHNICAL SERVICE FOR AN ISSUE ASSOCIATED WITH A REPORTED ALARM. THERE WAS NO HARM OR INJURY REPORTED. TROUBLESHOOTING ACTIVITIES BY PHILIPS REMOTE SERVICE TECHNICIAN INDICATED THE DEVICE WAS IN USE WITH A PATIENT AT THE TIME THE DEVICE ALARM OCCURRED. IT WAS REPORTED THE ALARM PROMPTED FOR MAINTENANCE OF THE VENTILATOR AND THE DEVICE WAS FULLY FUNCTIONAL. THE PATIENT WAS SWITCHED TO A DIFFERENT VENTILATOR TO CONTINUE WITH MONITORING. ONSITE SERVICE WAS PROVIDED BY PHILIPS. REVIEW OF THE DEVICE ERROR CODE LOG REVEALED ERROR CODE E-344 INDICATING AN OXYGEN BLENDING MODULE (OBM) ACCURACY ISSUE. THE DEVICE WAS RETURNED TO THE FACTORY FOR REPAIR. DUE TO THE OBM ERROR, THE OBM PRINTED CIRCUIT BOARD ASSEMBLY WAS REPLACED. THE SYSTEM MEETS THE SPECIFICATION FOR THE PERFORMED SERVICE AND IS RETURNED TO USE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE BLOWER MOTOR WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637216 ↗MalfunctionJan 26, 2026Display or Visual Feedback Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BLACK SCREEN OCCURRED ON A TRILOGY 202 VENTILATOR. THE DEVICE WAS NOT REPORTED TO BE IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THERE WAS NO ALLEGATION OF HARM OR INJURY. TRILOGY 202 VENTILATOR HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. GOOD FAITH EFFORT ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL INFORMATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24177656 ↗MalfunctionDec 4, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 202 VENTILATOR HAD A ERROR OCCUR DURING USE OF THE VENTILATOR WITH RED ALARM "VENTILATOR NEEDS MAINTENANCE" APPEARING ON THE SCREEN AND CAUSING THE INABILITY TO VENTILATE NORMALLY. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF A MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717744 ↗MalfunctionAug 15, 2025Electrical /Electronic Property Problem; Pressure Problem; Electrical /Electronic Property Problem; Pressure Problem
A TRILOGY O2 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, IT WAS CONFIRMED BY AN OPERATIONAL CHECK THAT "VENTILATOR SERVICE REQUIRED" ALARM SOUNDED. ERROR CODE E-344 INDICATING (LOW FLOW - OBM_AIR_FLOW_DRIFT_OUT_OF_RANGE) WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. IN CONCLUSION, THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE RAN FOR TWO HOURS AND PASSED THE PERFORMANCE TEST. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. THE TECHNICIAN STATES THEY SUSPECTED PART WAS DESTROYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22819465 ↗MalfunctionJul 7, 2025Device Sensing Problem; Device Sensing Problem
THE MANUFACTURER RECEIVED AN ALLEGATION OF A FLOW SENSOR MALFUNCTION. NO PATIENT HARM OR INJURY WERE REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22411506 ↗MalfunctionJun 17, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE FOR THE COMPLAINT OF LOW TIDAL VOLUME AND AN ERROR CODE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE CUSTOMER COMPLAINT WAS CONFIRMED. A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S OXYGEN BLENDER CIRCUIT BOARD AND SENSOR BOARD TO ADDRESS THE ISSUE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. THE DEVICE RAN FOR TWO HOURS AND PASSED THE PERFORMANCE TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22237395 ↗MalfunctionJun 17, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE CUSTOMER'S COMPLAINT WAS CONFIRMED. A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S OXYGEN BLENDER CIRCUIT BOARD TO ADDRESS THE ISSUE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. THE DEVICE RAN FOR TWO HOURS AND PASSED THE PERFORMANCE TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22237392 ↗MalfunctionJun 17, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE CUSTOMER'S COMPLAINT WAS CONFIRMED. A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S OXYGEN BLENDER CIRCUIT BOARD TO ADDRESS THE ISSUE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. THE DEVICE RAN FOR TWO HOURS AND PASSED THE PERFORMANCE TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22237391 ↗MalfunctionJun 17, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE CUSTOMER'S COMPLAINT WAS CONFIRMED. A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S OXYGEN BLENDER CIRCUIT BOARD TO ADDRESS THE ISSUE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. THE DEVICE RAN FOR TWO HOURS AND PASSED THE PERFORMANCE TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22237387 ↗MalfunctionJun 17, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S OXYGEN BLENDER CIRCUIT BOARD TO ADDRESS THE ISSUE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. THE DEVICE RAN FOR TWO HOURS AND PASSED THE PERFORMANCE TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22236245 ↗MalfunctionMay 28, 2025Circuit Failure; Circuit Failure
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS EVALUATED BY A FIELD SERVICE ENGINEER AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22093975 ↗MalfunctionFeb 6, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR MOTHERBOARD MALFUNCTION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. DURING INITIAL EVALUATION OF THE DEVICE BY A PHILIPS REMOTE SERVICE ENGINEER, IT WAS CONFIRMED THAT THE DEVICE'S MOTHERBOARD WAS FAULTY. IT IS SUGGESTED TO HAVE AN ONSITE CENTRAL PROCESSING UNIT CHECK. THE CUSTOMER IS REQUESTING TO BE CONTACTED REGARDING THE EVALUATION. IT IS NOTED THAT 'THE CASE IS BEING TRANSFERRED TO SALES HANDLING AND IS CONSIDERED INVALID' FOR REMOTE SERVICE. WITHOUT ANY FURTHER STEPS IF THE QUOTATION IS NOT ACCEPTED BY THE CUSTOMER, THE CASE WILL BE CLOSED WITHOUT FINAL SOLUTION AFTER CUSTOMER REFUSES OUR SERVICE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21322996 ↗MalfunctionJan 16, 2025Failure to Power Up; Failure to Power Up
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WOULD NOT POWER ON. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21173184 ↗MalfunctionDec 12, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20915348 ↗MalfunctionDec 2, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE MANUFACTURER'S EVALUATION OF THE DEVICE A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20819983 ↗MalfunctionNov 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS MALFUNCTIONING. THE PATIENT HAS RAPID BREATHING AND CANNOT INCREASE BLOOD OXYGEN SATURATION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: Dyspnea; Low Oxygen Saturation
MAUDE report 20794683 ↗MalfunctionNov 26, 2024Battery Problem; Battery Problem
THE MANUFACTURER RECIEVED AN ALLEGATION THAT THE DEVICE'S BUILT-IN BATTERY WAS TOO LOW AND DID NOT SUSTAIN THE CHARGE. THERE WAS NO PATIENT HARM REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20782540 ↗MalfunctionAug 20, 2024Circuit Failure; Circuit Failure
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE TRILOGY 202 DEVICE WOULDN'T OPERATE, AND THE SETTING SCREEN WOULDN'T OPEN. THE DEVICE'S SYSTEM BOARD AND OXYGEN BLENDER HOUSING WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS THEN TESTED AND WAS FOUND TO RUN FOR TWO HOURS WITHOUT ISSUE AND PASSED ALL PERFORMANCE TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20003844 ↗MalfunctionJul 1, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19652017 ↗MalfunctionJun 24, 2024Gas Output Problem; Gas Output Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S OXYGEN COULD NOT BE REGULATED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19600293 ↗MalfunctionApr 3, 2024Mechanical Problem; Mechanical Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S TIDAL VOLUME IS TOO LOW AND AN ALARM ERROR IS OCCURRING. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19033854 ↗MalfunctionMar 4, 2024Infusion or Flow Problem; Infusion or Flow Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING MINUTE VENTILATION AND TIDAL VOLUME VALUES DOUBLED. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18825545 ↗MalfunctionFeb 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE CONTINUOUSLY BEEPS CAUSING IT NOT TO WORK PROPERLY. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18791481 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K093905. One submission often covers many models, so check the product and lot details in each record.
- Z-1065-2016 · Jan 18, 2016 · TerminatedTrilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory su
- Z-1143-2014 · Feb 11, 2014 · TerminatedTrilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilog
- Z-2024-2012 · Apr 27, 2012 · TerminatedRespironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require m
Other Oximeter devices
- Trilogy Trilogy100 Ventilator, InternationalRespironics, Inc. · Oximeter8 deaths2,493 reports
- Trilogy Trilogy 202 Ventilator, United StatesRespironics, Inc. · Oximeter2 deaths1,594 reports
- HAMILTON-G5 159001Hamilton Medical AG · Oximeter18 deaths1,440 reports
- Trilogy Trilogy100 Ventilator, GermanyRespironics, Inc. · Oximeter696 reports
- Model EMV+ Vent, Army, MRI 799-EMVP-04Zoll Medical Corporation · Oximeter1 death605 reports
- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
- Model EMV+ Vent, Army, COMMERCIAL 799-EMVP-01-01Zoll Medical Corporation · Oximeter1 death497 reports
- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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